First MHRA/NICE aligned guidance due in June

The aligned pathway for UK drugs regulator MHRA and reimbursement authority NICE – aimed at slashing the time it takes for new medicines to reach patients – will start to deliver guidance in June, according to the agencies.

The new pathway, which will deliver simultaneous licensing and reimbursement decisions on new marketing applications, is due to start at the start of next month. 27 companies have signed up as early adopters, and the first treatments are now under appraisal under the programme, according to an update presented at the NICE Conference this week.

It will launch alongside a revised integrated scientific advice service, which the agencies say will offer "a single-entry point, meeting, and one payment" to make it easier for companies to get clarifications on regulations and the evidence required early in the development process, and provide a forum to discuss areas where conflicts can arise, such as clinical endpoints and patient populations in trials.

"The services announced today will help to bring safe, effective medicines to patients faster by aligning licensing and value assessment decisions," said Prof Jonathan Benger, chief executive of NICE. "They will give companies predictable timelines to support effective planning, tell them what evidence is required earlier in the process and help to remove unnecessary delays."

MHRA CEO Lawrence Tallon told the conference that the initiative is "about health and prosperity" and could see new therapies being available to patients between three and six months earlier.

"Our continued collaboration also makes the UK an even more attractive launch market for the global life sciences industry, so will boost R&D investment and economic growth in this country," he added.

The aligned pathway is part of the implementation of the new NHS 10-Year Plan and Life Sciences Sector Plan, which also include the creation of a new joint taskforce between NICE and the MHRA, an expansion of NICE's technology appraisal process to cover devices, diagnostics, and digital product with new powers to remove outdated tech from the NHS, and rolling re-evaluations of priority clinical pathways.

The new pathway has been cautiously welcomed by the Association of the British Pharmaceutical Industry (ABPI), which has identified poor patient access to medicines as one of the key weaknesses undermining the UK's global position in life sciences. The industry group has described it as "one of many necessary improvements in the UK health and life sciences ecosystem."

Pharmaceutical companies can join a webinar at 2pm to 3pm GMT on Wednesday, 25th March, to find out more about the aligned pathway and integrated scientific advice service and how and when to apply.